Post-acute Care for Patients With Hip Fracture

Hip Fractures Clinical Trial

Official title:

Home-Based Integrated Post-Acute Care Program for Hip Fracture

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287101
• Other study ID #: PAC for hip fracture
• Status: Completed
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2022
• Source: Taipei City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background and purpose: Hip fracture, a common injury occurred in people aged over 50, may result in disability, poor quality of life, and higher care stress for their families. Aging population and growing number of hip fractures have increased medical expenses, so developed countries implemented post-acute care (PAC) to reduce acute hospitalization, and to improve the quality of care. PAC services can be delivered by hospital/facility-based and home-based services. Previous studies showed that both services could significantly improve patients' activities of daily living and quality of life, and reduce readmissions, long-term care and costs. Taiwan has implemented PAC plan for hip fractures since 2017, but relevant evidences are limited. Therefore, the purpose of this study is to analyze the efficacy and cost-effectiveness of PAC for patients with hip fractures.

Description:

Methods: This is a prospective cohort study which will recruit patients aged over 50 with hip fractures receiving surgical treatment in the Taipei City Hospital. They will be provided home-based PAC, hospital-based PAC, or no formal PAC based on the medical judgment and patients/families' willingness. The period of PAC will be two to three weeks after the acute hospitalization. Assessments include physical function (30 seconds sit to stand, Barthel index, and Harris Hip Score), numerical pain rating scale, EuroQol instrument (EQ-5D), Caregiver Strain Index, and using of medical resources. The assessments will be on the day before discharge from acute hospitalization, and on the discharge day from post-acute care. The follow-up assessment will be at 1, 3, 6, and 12 months after operation. The cost-effectiveness ratio will be defined as the New Taiwan dollars paid for 1-unit improvement of functional performance and quality of life.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Aged = 50

2. First hip fracture

3. Stable medical condition

Exclusion Criteria:

1. Hip fracture caused by major trauma or pathological condition

2. Multiple fractures

3. Severe physical disability before the hip fracture

4. Unable to cooperate with treatment

5. Further inpatient treatment

Related Conditions & MeSH terms

• Activities of Daily Living
• Fractures, Bone
• Hip Fractures

Intervention

Other:
• Post-operative PT and OT
Strengthening exercise, range-of-motion exercise, functional training, balance training, adjustment for assistive devices, adaptation and modi?cation of the home environment, and patient/caregiver education

Locations

Country	Name	City	State
Taiwan	Taipei City Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei City Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-second sit to stand	Ask participants to cross their arms at the chest, and to perform sit to stand as more as possible within 30 seconds. Measure the repetitions the participants do. Higher repetition indicates more strength of lower extremities.	within 1 year
Primary	Activities of daily living Using the Barthel Index (BI)	Using the Barthel Index (BI) to measure participants' activities of daily living. The self-care domain is self-report by the patient or their families. The mobility domain is observed by the assessor. The greater score indicates more independence.	within 1 year
Primary	Functional performance of hip Using the Harris hip score (HHS)	Using the Harris hip score (HHS) to measure participants' functional performance of hip. The pain domain is self-report by the patient. The function, deformity, and range of motion domain are observed by the assessor. The greater score indicates the better functional performance of hip.	within 1 year
Primary	Pain intensity Using the numerical pain rating scale (NPRS)	Using the numerical pain rating scale (NPRS) to measure participants' pain intensity. Ask participants to report their pain intensity with the 11-point scale (from 0 no pain to 10 worst possible pain).	within 1 year
Primary	Quality of lives Using the EuroQol instrument (EQ-5D)	Part 1: Ask participants to measure their mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with the 3-point scale. The greater score indicates poor quality of life.	within 1 year
Primary	Quality of lives Using the EuroQol instrument (EQ-5D)	Part 2: Ask participants to measure their quality of life with a 20-cm visual analog scale. The greater score indicates a better quality of life.	within 1 year
Primary	Caregiver strain Using the caregiver strain index (CSI)	Using the caregiver strain index (CSI) to measure the strain of caregiver. Ask them to fill a 13-item questionnaire. Greater value indicates a higher strain.	within 1 year
Primary	Medical Costs	Ask participants to record their direct medical cost and indirect medical cost within one year after hip fracture.	within 1 year